MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

Model Number NX1000-3

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Calcium Deposits/Calcification (1758); Chest Pain (1776); Dyspnea (1816); Edema (1820); Pain (1994); Regurgitation (2259); Respiratory Failure (2484)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

The product meets all quality criteria and manufacturing specifications prior to release.The system one user guide includes fluid overload as a known and common risk associated with hemodialysis therapy and warns that hemodialysis may result in significant changes in the blood concentration of electrolytes and glucose and in the patient¿s volume status.Appropriate monitoring of the patient¿s hemodynamic, fluid, electrolyte, and acid-base balance should be performed regularly, per physician orders, to ensure appropriate response to therapy.Failure to do so could result in inappropriate therapy for the patient.

Event Description

A report was received on 02 nov 2019 from the caregiver regarding a (b)(6) male with medical history significant for end-stage renal disease, ~27 year history of type i diabetes, obesity, hypertension, low cardiac ejection fraction, an implantable cardioverter defibrillator (icd) with recent shock delivered and paroxysmal atrial fibrillation, stating an insufficient amount of programmed fluid was removed during home hemodialysis treatments.Per the caregiver, the patient had fluid overload and other lab values were out of range.Additional information was received on 07 nov 2019 from the home therapy nurse (htn) which revealed the patient had received a shock from his icd on (b)(6) 2019 unrelated to hemodialysis therapy.On (b)(6) 2019 the patient experienced acute chest pain, shortness of breath (o2 stat low 80s), acute respiratory failure with hypoxia, a-fib with rvr (hr 150-160) and fluid overload, and was admitted to hospital.Ecg performed on (b)(6) 2019 showed left axis deviation and left ventricular hypertrophy, cardiac echocardiogram showed the presence of hypokinesis, enlarged ventricles, calcification, valve thickening and regurgitation, cxr showed low lung volumes, physical examination confirmed the presence of rales and bilateral pitting edema of the legs, and lab results showed out of range results including low k+, calcium, sodium, hemoglobin and hematocrit.The patient received oxygen, electrolyte replacement, was commenced on oral eliquis 2.5mg bd, and had hemodialysis performed for 3 consecutive days.The patient was discharged (b)(6) 2019 with a discharge diagnosis of paroxysmal atrial fibrillation and acute respiratory failure with low oxygen, and continues to treat using the nxstage system one.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• Manufacturer (Section G): MEDIMEXICO S. DE R. L. DE C. V; av. valle imperial no. 10523; parque industrial valle sur; tijuana 22180 ; MX 22180
• Manufacturer Contact: paula rogalski ; nxstage medical, inc; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 9384882
• MDR Text Key: 168440380
• Report Number: 3003464075-2019-00070
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-3
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Weight: 130